rTMS-concurrent Behavioral Priming for Reducing Smoking Cravings
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorWest Virginia University
About this trial
The objective of this pilot clinical trial is to test the effects of different types of thinking strategies at the time of repetitive Transcranial Magnetic Stimulation (rTMS), applied to the left Dorsolateral Prefrontal Cortex (DLPFC), on smoking craving and brain activity. Participants will be individuals with moderate to high smoking dependence (smoking at least 8 cigarettes a day) who have no intention of quitting in the next 3 months and are eligible to have rTMS and functional magnetic resonance imaging (fMRI). The main objectives of the trial are:
1. To compare the craving-reducing effects of "upregulation" and "downregulation" of craving while looking at pictures related to cigarette smoking during rTMS versus no regulation of craving while looking at neutral pictures unrelated to smoking. 'Upregulation" is thinking about the immediate positive experience of smoking. "Downregulation" is thinking about the long-term negative consequences of smoking. 2. To examine changes in brain activity that accompany craving reductions produced by rTMS paired with upregulation and downregulation of craving while looking at pictures related to cigarette smoking versus no regulation of craving while looking at neutral pictures unrelated to smoking.
Following screening for eligibility, participants will be trained on how to do upregulation and downregulation of craving. The participants will then participate in 3 testing sessions. In each session, the participants will receive rTMS at 20Hz in 50 trains (2000 pulses total), followed immediately by fMRI. Sessions will take place 1-2 weeks apart and will differ in the type of thinking strategy participants will use while looking at pictures during the rTMS:
* upregulation of craving while viewing smoking-related images * downregulation of craving while viewing smoking-related images * no regulation of craving while viewing neutral smoking-unrelated images
The order of sessions will be randomized across participants.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Able to provide written informed consent, and to follow study procedures
Active cigarette smoker consuming at least 8 cigarettes a day for at least 6 months.
Dual use of cigarettes and e-cigarettes is permitted.
Disqualifiers
History of epilepsy or seizure disorder
History of cerebral vascular accident or cortical stroke
History of brain lesions (such as multiple sclerosis, tumor)
History of moderate or severe traumatic brain injury
Trial design
Design model
Single group
Treatments tested in this trial
Repetitive transcranial magnetic stimulation (rTMS)
DevicerTMS: rTMS is a form of non-invasive brain modulation. High-frequency rTMS will be administered. Pulses will be delivered at the frequency of 20Hz, in 50 trains of 40 pulses, 2000 pulses in total. Behavioral priming with regulation of craving: During rTMS, participants will look at pictures either related or unrelated to smoking. When looking at pictures related to smoking, participants will either upregulate cravings by thinking about the immediate positive experience of smoking or downregulate cravings by thinking about long-term negative consequences of smoking. When looking at neutral pictures unrelated to smoking, participants will not regulate their cravings.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Active rTMSExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in self-reported smoking cravings
Change in self-reported smoking cravings following high-frequency repetitive transcranial magnetic stimulation (rTMS) of the dorsolateral prefrontal cortex paired with upregulation of craving during smoking cue exposure and downregulation of craving during smoking cue exposure relative to neutral cue exposure and no regulation of craving. Craving will be rated using the Tobacco Craving Questionnaire immediately following rTMS and on 1-4 Likert scale (1 = not at all; 4 = very much) in the course of cue exposure in fMRI.
Time frame
within 1 hour following the delivery of rTMS2
Change in neural activation during regulation of craving
Change in neural activation accompanying regulation of craving following high-frequency repetitive transcranial magnetic stimulation (rTMS) of the dorsolateral prefrontal cortex paired with upregulation of craving during smoking cue exposure and downregulation of craving during smoking cue exposure relative to neurtral cue exposure and no regulation of craving. Neural activation will be measured using functional magnetic resonance imaging (fMRI).
Time frame
within 1 hour following the delivery of rTMSSecondary outcomes
1
Change in delay discounting performance for cigarettes
Change in delay discounting performance for cigarettes following high-frequency repetitive transcranial magnetic stimulation (rTMS) of the dorsolateral prefrontal cortex paired with upregulation of craving during smoking cue exposure and downregulation of craving during smoking cue exposure relative to neutral cue exposure and no regulation of craving. Delay discounting performance will be measured in fMRI using a delay discounting task optimized for fMRI with the commodity being cigarettes.
Time frame
within 1 hour following the delivery of rTMS2
Change in neural activation during delay discounting performance for cigarettes
Change in neural activation accompanying delay discounting performance for cigarettes following high-frequency repetitive transcranial magnetic stimulation (rTMS) of the dorsolateral prefrontal cortex paired with upregulation of craving during smoking cue exposure and downregulation of craving during smoking cue exposure relative to neutral cue exposure and no regulation of craving. Neural activation will be measured using fMRI.
Time frame
within 1 hour following the delivery of rTMSOther outcomes
1
Resting-state brain activity
Resting-state brain activity following high-frequency repetitive transcranial magnetic stimulation (rTMS) of the dorsolateral prefrontal cortex paired with upregulation of craving during smoking cue exposure and downregulation of craving during smoking cue exposure relative to neutral cue exposure and no regulation of craving. Resting-state brain activity will be measured using fMRI.
Time frame
within 1 hour following the delivery of rTMSSponsors and contacts
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Source ClinicalTrials.gov